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510(k) K933178

GDC 3509 by Deringer-Ney, Inc. — Product Code EJT

K933178 is an FDA 510(k) premarket notification submitted by Deringer-Ney, Inc. for the device "GDC 3509". The FDA issued a decision of Substantially Equivalent on October 14, 1993. The device falls under product code EJT (Alloy, Gold-Based Noble Metal), a Class II device regulated under 21 CFR 872.3060. Deringer-Ney, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1993
Date Received
June 30, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Gold-Based Noble Metal
Device Class
Class II
Regulation Number
872.3060
Review Panel
DE
Submission Type

Other clearances by Deringer-Ney, Inc.

  • K930482 — DENTAL CASTING ALLOY, MODIFICATION - PF-3 (March 31, 1993)
  • K930481 — DENTAL CASTING ALLOY MODIFICATION-PF-4 (March 31, 1993)
  • K925273 — GDC 3445 (December 21, 1992)
  • K920922 — GDC 3367 (May 5, 1992)
  • K920060 — DENTAL SOLDER ALLOY (April 2, 1992)
  • K920887 — GDC-3338, DENTAL SOLDER ALLOY (March 19, 1992)
  • K910065 — GDC-3200 DENTAL SOLDER (March 15, 1991)
  • K904695 — GDC-1501 (January 2, 1991)
  • K904614 — GDC-1475 (December 19, 1990)
  • K901532 — GDC 3084 CASTING ALLOY (May 2, 1990)

Other clearances for product code EJT

  • K052463 — PROMETAL HN86 (October 14, 2005)
  • K041378 — BIO 60 (August 2, 2004)
  • K040672 — PORTA REFLEX (May 27, 2004)
  • K040524 — PORTA SOLDER 1090 W (May 20, 2004)
  • K040043 — NDX-40 ALLOY (March 3, 2004)
  • K034049 — HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, (March 1, 2004)
  • K033279 — GOLD DENTAL CASTING ALLOYS (January 15, 2004)
  • K033446 — APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82 (November 13, 2003)
  • K033435 — E-SARANG 86, DM78, DM55 (November 12, 2003)
  • K032320 — APPOLLO 3 ALLOY (October 1, 2003)

FDA data resources